510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925591Substantially Equivalent

Meridian Medical Systems Hyper Inflation Bay Syst

Merit Medical Systems, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925591 is the FDA 510(k) clearance record for MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K925591.

Clearance record

Decision date
Received
(315 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Merit Medical Systems, Inc. 8102 Woodland Dr/., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code BZR

Trailing 12 months

FDA records hold no clearances under product code BZR in the trailing twelve months.

FDA records show no clearances under product code BZR in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260